Scientist/Sr. Scientist/Associate Director, Clinical Assay Scientist
Responsible for managing a portfolio of clinical assays required for the clinical development of investigational, CRISPR gene-edited cell therapies. This person will be a core member of the drug development team and is responsible for identifying clinical assays required for the trials (in collaboration with the Medical Director), developing novel assays (in collaboration with PCAD assay developers), identifying and qualifying appropriate clinical vendors, transferring assays to the vendors, and managing the vendor logistics and relationships.
- Collaborate with discovery/pre-clinical scientists, translational pharmacologist, Clinical Scientist/Medical Director and Clinical Operations
- Identify and document assays required for clinical trials (primary endpoints, secondary endpoints and exploratory assays)
- Identify and document assays required for planned exploratory research as per the BMx and exploratory research plan
- Collaborate with assay development scientists at CRISPR Therapeutics to ensure that all novel assays are developed in a high quality and timely manner
- Identify and help qualify appropriate clinical vendors to perform all clinical assays required for a trial
- Communicate patient sample requirements for all clinical assays and exploratory research purposes to the Clinical Scientist and/or Trial Manager
- Transfer novel assays to the contracted clinical vendor
- Develop “sample journey” plans for all samples required for clinical assay and exploratory research
- For samples requiring biorepository storage, ensure that sample logistics are in place with the biorepository
- Ensures that assays are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO)
- Manage the progress and logistics related to the conduct of clinical assays during the trial
- Manage vendor relationships and troubleshoot where necessary
- MS degree or higher educational training in a field related to the health sciences
- At least 5 years of experience in clinical trials in and/or clinical assay development/management in a biotech or pharmaceutical setting
- An understanding of clinical drug development and requirements for associated clinical assays
- A PhD or PharmD in a health-related field
- 10+ years of experience in clinical trials and/or clinical assay development/management in a biotech or pharmaceutical setting
- Experience in biomarker and/or genomic-related assay development or research in the pharmaceutical/biotech setting
- Understanding of the evolving regulatory requirements for cell and gene therapy (OTAT) products in the US or ATMP products in Europe.
- Experience with development of Cell and Gene Therapy or ATMP products, and development requirements
- Experience in clinical assay development
- Experience in developing immuno-oncology therapies, including CAR T therapies
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.